Associate Director, Clinical Operations

Associate Director - Clinical Operations ImpactBio is preparing for a potential new client. This would be a full-time position with ImpactBio. We are seeking resumes from experienced Associate Directors, Clinical Operations capable of planning and executing early-stage clinical trials (first in human including normal healthy volunteer studies, Phase 1 and Phase 2). The Associate Director, Clinical Operations will interface with internal and external stakeholders to plan, execute and problem solve before and during the life of clinical trials in several therapeutic areas (Oncology, Immunology and Infectious Diseases). If you are a collaborative, relentless problem solver that has a passion for impact, then you will want to apply! Go to to view the job and apply. The Role: The Associate Director, Clinical Operations will focus on site- and Contract Research Organization (CRO)-facing interactions to ensure smooth execution of studies, including start-up, drug and budget forecasting, and acquisition of detailed, high-quality clinical (including safety and efficacy) and translational data to support evaluation of the drugs under study. Clearly and efficiently communicating with cross-functional team members to achieve these goals. The Associate Director will serve as the clinical operations lead for at least one study in addition to leading a growing team of operations staff. This position offers a competitive compensation & benefits package including Medical, Dental & Vision insurance, car allowance, fuel reimbursement, as well as a robust 401K plan and other perks. What You Will Be Doing: Develop clinical operations strategy for each agent in development, either directly or by leading study staff depending on the stage of the agent. Cross-functional collaboration to develop needed outputs such as protocols, annual safety reports and investigator brochure, clinical study reports, presentations, regulatory submissions and publications. Evaluate external collaborators including Contract Research Organizations (CROs) and sites and select the best candidates for each needed function. Develop vendor scope of work, contract, quality, monitoring and budget. Develop and manage standard operating procedures (SOPs) for the organization and its external collaborators. Ensure GCP compliance. Continuously evaluate performance of external collaborators and vendors, troubleshoot and recommend a path forward when challenges are encountered. Develop and manage study timelines, working with internal partners (including but not limited to clinical development, clinical pharmacology and other quantitative functions, data management, biomarkers and translational, CMC, regulatory affairs and project management). Attend and, where appropriate, present at study site initiation meetings and study calls. Patient recruitment planning and forecasting. Other responsibilities as necessary to perform position. Must Haves: Minimum 8 years of experience in clinical operations across at least 2 therapeutics areas. B.A. or B.S. required, advanced degree preferred. Experience managing CROs and vendors both in the US and in international clinical trials. Experience serving as the clinical operations lead for one or more clinical programs. Experience in site initiation visits, site management, data cuts for publication and regulatory requirements. Understanding of the drug development process from IND to NDA. Dedication to collaborative work in a fast-paced environment; open-mindedness to shifting strategy in a data-guided manner. Ability to communicate effectively and efficiently and willingness to train other team-members within and outside of Clinical Operations. Experience in large Pharma and biotech and with biomarker-selected studies preferred but not required. Experience with at least one direct report is preferred, but a strong candidate with hands-on experience and a growth mindset will be considered. Company Overview: ImpactBio partners with the Life Sciences Industry to deliver customized Commercial and Clinical teams that help clients launch and scale. We pride ourselves on doing things differently, with a focus on exceeding expectations for our employees, clients, and the HCPs & patients we serve. Ready to make an impact? Go to to view the job and apply. ImpactBio is an equal opportunity employer M/F/V/D. While we appreciate your interest, only qualified candidates will be considered.

Created: 2025-03-12